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Docetaxel and Carboplatin Followed by a Dose-Ranging Study of Oral Capecitabine, Weekly Docetaxel, and Concomitant External Beam Radiotherapy for the Treatment of Patients With Stage II-III Carcinoma of the Esophagus and Gastro-Esophageal Junction


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Esophageal Neoplasms

Thank you

Trial Information

Docetaxel and Carboplatin Followed by a Dose-Ranging Study of Oral Capecitabine, Weekly Docetaxel, and Concomitant External Beam Radiotherapy for the Treatment of Patients With Stage II-III Carcinoma of the Esophagus and Gastro-Esophageal Junction


This dose-ranging trial is designed to establish the phase II dose of capecitabine that can
safely be given with docetaxel and radiation therapy for the treatment of patients with
cancer of the esophagus and gastroesophageal junction. The docetaxel dose of 15 mg/m2/week,
5-fluorouracil dose of 200 mg/m2/week, and 50.4 Gy of thoracic radiation has been found to
be the recommended doses from our initial phase I trial (DMS D9724). The Phase I study has
been modified in an attempt to improve the pathological complete response rate by increasing
the 5-fluorouracil exposure during thoracic radiation by replacing it with oral
capecitabine. Capecitabine generates 5-fluorouracil selectively in tumor cells. This
sequentially designed study of EUS staging, molecular analysis, neoadjuvant chemotherapy,
concomitant chemotherapy and radiation, and surgical resection continues to expand our
collaborative experience at Dartmouth Hitchcock in the treatment of cancer of the esophagus
and gastroesophageal junction.


Inclusion Criteria:



- Esophageal or gastroesophageal junction cancer that is locally advanced and
surgically resectable (stage II or III disease).

- No prior therapy.

- Adequate organ function.

Exclusion Criteria:

- Evidence of metastasis (celiac axis lymph nodes are allowed).

- Cervical esophageal tumors.

- Peripheral or auditory neuropathy grade >= 2.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose of oral capecitabine in combination with fixed doses of weekly docetaxel and concurrent radiation for the treatment of patients with clinical stage II-III cancer of the esophagus and gastroesophageal junction.

Outcome Time Frame:

Enrollment of first subject to accural of last subject/ and data analysis

Safety Issue:

No

Principal Investigator

James R Rigas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Norris Cotton Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

D-9939

NCT ID:

NCT00153881

Start Date:

February 2000

Completion Date:

June 2013

Related Keywords:

  • Esophageal Neoplasms
  • Esophageal Cancer
  • Trimodality
  • Capecitabine
  • Xeloda
  • Gastro-esophageal Neoplasm
  • Carcinoma of the Esophagus
  • Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location

Norris Cotton Cancer CenterLebanon, New Hampshire  03756